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AN EDUCATIONAL INITIATIVE BY ZYDUS
Author(s) : Grotz VL, Sunyer XP, Jr DP, Roberts A, Trout JR Publication Name : Regulatory Toxicology and Pharmacology,Volume 88;Pages 22-33,ISSN 0273-2300 . doi: 10.1016/j.yrtph.2017.05.011 Publication : 2017

During the development of Sucralose as a sweetener, there were more than 100 studies that investigated of its possible effects on carbohydrate metabolism, uptake and storage, chronic studies in model animal species, and human tolerance studies in both normoglycemic and hyperglycemic volunteers. The European Food Safety Authority (EFSA) permits the use of non-nutritive sweeteners, including sucralose, in place of nutritive sweeteners for reducing calories in foods and food products. With the recent discovery of gut sweet receptors, there is speculation that NNS, including sucralose, may affect glucose control.

The current RCT investigates the effect of sucralose consumption on glucose homeostasis in normoglycemic healthy volunteers by evaluating key measures in glucose and insulin homeostasis, including HbA1c, fasting and post-prandial glucose, insulin and C-peptide levels. This was an outpatient study, with 4 wks of screening, 12 wks of test period and 4 wks of follow up. In total, 47 male volunteers were given ∼333.3 mg encapsulated sucralose or placebo 3x/day at mealtimes and OGTT was conducted at five different stages. The levels of HbA1c, fasting glucose, insulin, and C-peptide were measured weekly and OGTTs were conducted in clinic overnight, following overnight fasting. OGTT was done twice during the screening phase, twice during the test phase, and once at follow-up.

Throughout the study, glucose, insulin, C-peptide, and HbA1c levels were within normal range. The study reported no statistically significant difference between the treatment group and placebo group for the parameters measured. Also, no clinically meaningful differences, in time to peak levels or return towards basal levels in OGTTs, and no treatment group differences in mean glucose, insulin, or C-peptide AUC change from baseline were observed. On comparing this data with relevant clinical trials and studies of gastrointestinal sweet taste receptors, the collective evidence supported the understanding that sucralose had no effect on glycemic control.

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